Power Dental USA

Basic Information

• Brand Name: Power Dental USA
• Primary DI: D9431303D00
• Version / Model: 1303D
• Catalog Number: 1303D
• Company Name: Power Dental U.S.A. Inc.
• Labeler DUNS: 081305064
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-13
• Public Version: 3
• Public Version Date: 2022-03-24
• Public Version Status: Update
• Public Device Record Key: 6a9811d5-5a8f-4135-87fc-671c5698a5e3

Device Description

SCALERS ANTERIOR N128/N128 DOUBLE END

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EMN	SCALER, PERIODONTIC	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35811	Dental excavator, reusable	A hand-held manual dental instrument designed for cutting, scraping, and removing the carious dentine of a decayed tooth or other pathological bone tissue within the oral cavity. It is made of high-grade stainless steel typically designed as a double-ended instrument, having a central handle, with small, sharp, spoon-, scoop-, or spatula-shaped blades that have sharp cutting/gouging edges. This is a reusable device.	No	Active
35320	Manual dental scaler, reusable	A hand-held dental instrument designed for removing calculus and other accretions from the surface and between the teeth during dental cleaning and periodontal (gum) therapy. It is typically designed as a one-piece instrument with a pointed, distal end of various shapes and sizes. Also known as a periodontic scaler, it can be a single-ended or double-ended instrument with a handle at the proximal end or positioned centrally. It is usually made of high-grade stainless steel. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D9431303D00	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]